Most statistical consultants and experts can plan and perform statistical analyses, but few are experienced in the strategic considerations that are essential components in the development of a new medicine. Even fewer are experience and expert in safety, pharmacovigilance and benefit to risk. Dr. Rockhold brings more than 40 years of global experience in the statistical aspects of drug development and the regulatory process. He will work with you to design research plans, clinical trials, and safety and benefit to risk strategies.

Dr. Rockhold experience base includes directing statistical and clinical aspects of global submissions for more than 100 new molecular entities in every therapeutic area including vaccines and consumer products, new indications, and combination products. He has presented personally at FDA advisory committee meetings, Japanese and European regulatory agencies, National Academy of Science, Institute of Medicine, White Office of Technology and Science and is currently an adviser to the Patient Centered Outcomes Research Institute as part of the Affordable Care Act.   He also has unique and international recognized experience in the areas of public data disclosure and scientific transparency.

This diverse and unique set of experiences will add significant value to your research projects.

WHY CLINICAL RESEARCH DESIGN?

Clinical Research Design can help:

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THE APPROACH

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